Pharmacy DailyPharmacy Daily | FDA speaks out

THE US Food and Drug Administration has issued warning letters to Johnson & Johnson, the CVS Corporation and the Walgreen Company, regarding unproven claims about their respective mouth wash products. According to the agency the companies’ Listerine Total Care Anticavity Mouthwash (J&J), CVS Complete Care Anticavity Mouthwash (CVS) and Walgreen Mouth Rinse Full Action (Walgreen), all make claims that their products either remove plaque above the gum line, promote healthy gums or prevent gum disease. In actuality the FDA says that whilst the products’ active ingredient sodium fluoride is effective in preventing cavities, no evidence has been offered up to show that it removes plaque or prevents gum disease. The three companies now have 15 days to “take appropriate action” to correct the violations. MEANWHILE the FDA has also issued its final ruling on what safety information must be reported during clinical trials of investigational drugs and biologics. According to the rule within 15 days of becoming aware of an occurrence companies must file a report with the FDA that includes: findings that suggest a significant risk to participants and serious suspected adverse reactions that occur at a higher rate than expected. The report must also include info on serious adverse events from bioavailability studies which determine what percentage and at what rate drug is absorbed by the bloodstream and bioequivalence studies which determine whether a generic drug has the same bioavailability as the brand name drug.

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